Virtually all anaerobic infections arise endogenously. Anaerobic bacteria are a part of the normal flora of the skin. They also exist prevalently on all mucous membrane surfaces as indigenous flora. Given the proper circumstances and opportunity to penetrate tissues, anaerobes from the indigenous flora set up infections, such as gas gangrene, vulvovaginal abscess, chronic sinusitis, and Vincent's disease. While treatment with hyperbaric oxygen or hydrogen peroxide may be effective against certain anaerobe infections, there is a need for safe and effective methods of treating or preventing anaerobe infections generally.
Periodontal diseases are believed to involve anaerobic bacterial infections. Periodontal disease affects the periodontum, which is the investing and supporting tissues surrounding a tooth (i.e., the periodontal ligament, the gingiva, and the alveolar bone). Gingivitis and periodontitis are inflammatory disorders of the gingiva and the periodontal ligament, respectively. Gingivosis and periodontosis are more severe conditions involving degenerative disorders of the tissue. Combinations of inflammatory and degenerative conditions are termed periodontitis complex.
Periodontal disease is a major cause of tooth loss in adults. Tooth loss from periodontal disease is a significant problem beginning at age 35, but even by age 15 it is estimated that about 4 out of 5 persons already have gingivitis and 4 out of 10 have periodontitis.
While good oral hygiene, as achieved by brushing the teeth with a cleansing dentifrice, may help reduce the incidence of periodontal disease, it does not necessarily prevent or eliminate its occurrence. This is because microorganisms contribute to both the initiation and progress of periodontal disease. Thus, in order to prevent or treat periodontal disease, these microorganisms must be suppressed by some means other than simple mechanical scrubbing. Towards this end, there has been a great deal of research aimed at developing therapeutic dentifrices, mouthwashes, and methods of treating periodontal disease which are effective in suppressing these microorganisms.
It is the purpose of the present invention to provide a method for treating or preventing topically-treatable anaerobe infections, especially diseases of the oral cavity, in humans or lower animals by utilizing a monoperphthalic acid compound, or its pharmaceutically-acceptable salts or esters. Further, the present invention provides therapeutic rinses, especially mouth rinses, as well as toothpastes and gels, chewing gums, mouth sprays, lozenges, and sachets, containing a monoperphthalic acid compound, or its pharmaceutically-acceptable salts or esters, which are safe and effective in killing, and for a period of time suppressing the growth of, the microorganisms (especially anaerobic microorganisms) which cause topically-treatable anaerobe infections, especially diseases of the oral cavity, such as gingivitis, periodontal disease, and acne. In addition, the present invention relates to kits for making mouth rinses with limited concentrations of a monoperphthalic acid compound.